Trial Outcomes & Findings for Move For Your Health for Older Cancer Survivors (NCT NCT05582889)
NCT ID: NCT05582889
Last Updated: 2025-11-10
Results Overview
The number of adverse events attributable to or possibly attributable to the intervention will be tracked; defined as any condition that is life-threatening and results in overnight hospitalization or a physical or cardiac event serious enough to require medical attention. The number of adverse events is part of assessing feasibility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
24-weeks
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Experimental: Immediate Fitbit Intervention
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Experimental: Immediate Fitbit Intervention
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Overall Study
Health event
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
Baseline Characteristics
Move For Your Health for Older Cancer Survivors
Baseline characteristics by cohort
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
32 Participants
n=20 Participants
|
64 Participants
n=40 Participants
|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
72.0 years
STANDARD_DEVIATION 5.0 • n=20 Participants
|
72.8 years
STANDARD_DEVIATION 5.7 • n=40 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=20 Participants
|
46 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race-ethnicity · Hispanic
|
10 Participants
n=5 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race-ethnicity · non-Hispanic White
|
20 Participants
n=5 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race-ethnicity · Other
|
2 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
32 participants
n=20 Participants
|
64 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: up to 1-yearThe number of months to accrue the study sample. Accrual is part of assessing feasibility.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Time to Accrual Goal
|
9 months
|
9 months
|
PRIMARY outcome
Timeframe: 24-weeksThe proportion of participants who complete the study out of the number randomized to one of two study arms. Retention is part of assessing feasibility.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Study Participant Retention Rate
|
27 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: 24-weeksThe proportion of participants who complete all five health coaching calls and wear the Fitbit activity tracker at least 67 days (67 days = 80% x 12 weeks). Adherence is part of assessing feasibility.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Study Participant Adherence Rate
|
29 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: 12-weeksThe number of adverse events attributable to or possibly attributable to the intervention will be tracked; defined as any condition that is life-threatening and results in overnight hospitalization or a physical or cardiac event serious enough to require medical attention. The number of adverse events is part of assessing feasibility.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Number of Adverse Events Attributable to the Study
|
0 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: 12-weeksSelf-reported physical function will be assessed using the PROMIS® Item Bank v2.0 - Physical Function - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of better physical functioning.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Physical Function
|
0.03 points
Standard Deviation 4.25
|
1.22 points
Standard Deviation 3.77
|
PRIMARY outcome
Timeframe: 24-weeksThe number of adverse events attributable to or possibly attributable to the intervention will be tracked; defined as any condition that is life-threatening and results in overnight hospitalization or a physical or cardiac event serious enough to require medical attention. The number of adverse events is part of assessing feasibility.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Number of Adverse Events Attributable to the Study
|
0 adverse events
|
1 adverse events
|
SECONDARY outcome
Timeframe: 12-weeksPhysical performance will be objectively measured using the 30-second chair stand test, measured by the number of times a person comes to a full standing position from a chair in 30 seconds. Scores range from zero (cannot perform the test) to 30 or higher, with a higher number of chair stands representing stronger leg strength.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in the Number of Chair Stands During the 30-second Chair Stand Test
|
1.0 chair stands
Interval -1.0 to 2.0
|
0.5 chair stands
Interval -0.5 to 1.0
|
SECONDARY outcome
Timeframe: 12-weeksPhysical performance will be objectively measured using the 4-stage balance test. The 4-stage balance test includes standing in each of four positions for up to 10 seconds: 1) feet side-by-side; 2) semi-tandem stand \[one foot slightly behind but touching the other foot\]; 3) tandem stand \[one foot in front of the other; heel touching toe\]; and 4) stand on one foot. Scores range from zero (participant refused, failed, or excluded from side-by-side test) to 5 (all four positions held for maximum time). Higher scores represent better balance.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Balance Score During the 4-stage Balance Test.
|
0.0 points
Standard Deviation 0.5
|
0.1 points
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 12-weeksThe activPAL accelerometer/inclinometer will be used to measure steps per day. Participants will be asked to wear the monitor for 7-days. Average daily steps will be calculated as the total steps divided by the number of days the monitor was worn.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=31 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=31 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Number of Steps Per Day
|
1168 steps per day
Standard Deviation 2285
|
69 steps per day
Standard Deviation 1495
|
SECONDARY outcome
Timeframe: 12-weeksThe activPAL accelerometer/inclinometer will measure the daily minutes spent in light-intensity stepping. The average daily minutes of light-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Light-intensity stepping is defined as stepping at a cadence between 75 and 99 steps per minute.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=31 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=31 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Objective Measures of Light-intensity Physical Activity
|
16.4 minutes per day
Standard Deviation 30.7
|
0.0 minutes per day
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: 12-weeksThe activPAL accelerometer/inclinometer will measure the daily minutes spent in moderate-intensity stepping. The average daily minutes of moderate-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Moderate-intensity stepping is defined as stepping at a cadence of at least 100 steps per minute.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=31 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=31 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Objective Measures of Moderate-intensity Physical Activity
|
8.7 minutes per day
Standard Deviation 17.4
|
-1.1 minutes per day
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 12-weeksThe activPAL accelerometer/inclinometer will measure minutes spent in sedentary activities (not including sleep). The average daily minutes of sedentary time will be the total minutes divided by the number of days the activPAL monitor was worn.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=31 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=31 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Objective Measures of Sedentary Activity
|
-24.6 minutes per day
Standard Deviation 83.1
|
2.9 minutes per day
Standard Deviation 57.4
|
SECONDARY outcome
Timeframe: 12-weeksSelf-reported fatigue will be assessed using the PROMIS® Item Bank v1.0 - Fatigue - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse fatigue.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Fatigue
|
-1.38 points
Standard Deviation 5.76
|
1.09 points
Standard Deviation 3.79
|
SECONDARY outcome
Timeframe: 12-weeksSelf-reported pain will be assessed using the PROMIS® Item Bank v1.0 - Pain Interference - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse pain.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Pain
|
1.38 points
Standard Deviation 7.38
|
-0.56 points
Standard Deviation 4.28
|
SECONDARY outcome
Timeframe: 12-weeksSelf-reported sleep disturbance will be assessed using the PROMIS® Item Bank v1.0 - Sleep Disturbance - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of greater sleep disturbance.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Sleep Disturbance
|
-0.78 points
Standard Deviation 5.74
|
0.50 points
Standard Deviation 4.59
|
SECONDARY outcome
Timeframe: 12-weeksSelf-reported sleep impairment will be assessed using the PROMIS® Item Bank v1.0 - Sleep-Related Impairment - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater sleep impairment.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Sleep Impairment
|
0.81 points
Standard Deviation 2.98
|
0.28 points
Standard Deviation 4.88
|
SECONDARY outcome
Timeframe: 12-weeksSelf-reported ability to participate in social roles and activities will be assessed using the PROMIS® Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater social participation.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Social Participation
|
1.22 points
Standard Deviation 6.93
|
0.06 points
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: 12-weeksSelf-reported anxiety will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater anxiety.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Anxiety
|
0.91 points
Standard Deviation 3.11
|
-0.25 points
Standard Deviation 4.47
|
SECONDARY outcome
Timeframe: 12-weeksSelf-reported depression will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Depression - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater depression.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Depression
|
1.28 points
Standard Deviation 4.17
|
0.03 points
Standard Deviation 3.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksRisk for falls will be assessed by the Falls Efficacy Scale International. Scores range from 16 to 64, with higher scores representing greater concern about falling.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Fall Risk
|
0.0 points
Interval -2.0 to 1.0
|
0.0 points
Interval -2.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksRisk for falls will be assessed by the Falls Efficacy Scale International. Scores range from 16 to 64, with higher scores representing greater concern about falling.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Fall Risk
|
0.0 points
Interval -1.5 to 0.5
|
0.0 points
Interval -1.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeks4 items using a 5-point scale to measure support from family and friends while making changes to physical activity. Response items include never, once, sometimes, almost every day, and every day. Total scores range from 0 to 16; higher scores are indicative of greater social support for physical activity.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Social Support for Physical Activity
|
0.0 points
Interval -1.0 to 1.5
|
0.0 points
Interval -1.5 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeks4 items using a 5-point scale to measure support from family and friends while making changes to physical activity. Response items include never, once, sometimes, almost every day, and every day. Higher scores are indicative of greater social support for physical activity.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Social Support for Physical Activity
|
0.0 points
Interval -1.0 to 2.0
|
0.0 points
Interval -1.5 to 2.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksMultidimensional Outcome Expectations for Exercise Scale includes 15 items to assess physical, social, and self-evaluative beliefs about the consequences of being physically active. Response items include strongly disagree, disagree, neutral, agree, and strongly agree. Scores range from 15 to 75, with higher scores indicative of higher levels of outcome expectations for exercise.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Outcome Expectations
|
0.0 points
Interval -3.0 to 3.0
|
-1.0 points
Interval -3.0 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksMultidimensional Outcome Expectations for Exercise Scale includes 15 items to assess physical, social, and self-evaluative beliefs about the consequences of being physically active. Response items include strongly disagree, disagree, neutral, agree, and strongly agree. Scores range from 15 to 75, with higher scores indicative of higher levels of outcome expectations for exercise.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Outcome Expectations
|
-1.0 points
Interval -5.0 to 2.0
|
0.0 points
Interval -4.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksBehavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation. Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise. Change in BREQ2 Relative Autonomy Index (RAI) is a single score derived from subscales. Subscales are weighted; RAI provides the degree to which a participant feels self-determined. Higher, positive scores indicate greater relative autonomy; whereas lower negative scores indicate more controlled regulation.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Motivation
|
1.1 points
Standard Deviation 4.2
|
-0.4 points
Standard Deviation 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksBehavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation. Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise. Behavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation. Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise. Change in BREQ2 Relative Autonomy Index (RAI) is a single score derived from subscales. Subscales are weighted; RAI provides the degree to which a participant feels self-determined. Higher, positive scores indicate greater relative autonomy; whereas lower negative scores indicate more controlled regulation.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Motivation
|
-1.2 points
Standard Deviation 4.3
|
1.6 points
Standard Deviation 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: post-intervention (end of 12-week intervention)Perceived Autonomy Support - Sport Climate Questionnaire (short form) includes 15 items to assess autonomy support of the health coach to characterize the quality of the social environment for influencing motivation to exercise. Mean individual scores range from 1 to 7, with higher scores indicating greater autonomy support from the health coach. Total score ranges from 7 (low autonomy) to 105 (high autonomy). Measured after the intervention for both groups; note: this survey was not administered prior to the intervention.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=26 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=26 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Perceived Autonomy Support
|
101.5 points
Interval 96.0 to 105.0
|
99.0 points
Interval 96.0 to 105.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksSelf-reported physical function will be assessed using the PROMIS® Item Bank v2.0 - Physical Function - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of better physical functioning.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Physical Function
|
1.31 points
Standard Deviation 3.93
|
0.22 points
Standard Deviation 3.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksPhysical performance will be objectively measured using the 30-second chair stand test, measured by the number of times a person comes to a full standing position from a chair in 30 seconds. Scores range from zero (cannot perform the test) to 30 or higher, with a higher number of chair stands representing stronger leg strength.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in the Number of Chair Stands During the 30-second Chair Stand Test
|
0.0 chair stands
Interval 0.0 to 1.0
|
0.0 chair stands
Interval 0.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksPhysical performance will be objectively measured using the 4-stage balance test. The 4-stage balance test includes standing in each of four positions for up to 10 seconds: 1) feet side-by-side; 2) semi-tandem stand \[one foot slightly behind but touching the other foot\]; 3) tandem stand \[one foot in front of the other; heel touching toe\]; and 4) stand on one foot. Scores range from zero (participant refused, failed, or excluded from side-by-side test) to 5 (all four positions held for maximum time). Higher scores represent better balance.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Balance Score During the 4-stage Balance Test.
|
0.1 points
Standard Deviation 0.5
|
0.0 points
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksThe activPAL accelerometer/inclinometer will be used to measure steps per day. Participants will be asked to wear the monitor for 7-days. Average daily steps will be calculated as the total steps divided by the number of days the monitor was worn.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=31 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=31 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Number of Steps Per Day
|
296 steps per day
Standard Deviation 1828
|
542 steps per day
Standard Deviation 2699
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksThe activPAL accelerometer/inclinometer will measure the daily minutes spent in light-intensity stepping. The average daily minutes of light-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Light-intensity stepping is defined as stepping at a cadence between 75 and 99 steps per minute.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=31 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=31 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Objective Measures of Light-intensity Physical Activity
|
6.3 minutes per day
Standard Deviation 24.4
|
9.8 minutes per day
Standard Deviation 26.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksThe activPAL accelerometer/inclinometer will measure the daily minutes spent in moderate-intensity stepping. The average daily minutes of moderate-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Moderate-intensity stepping is defined as stepping at a cadence of at least 100 steps per minute.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=31 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=31 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Objective Measures of Moderate-intensity Physical Activity
|
3.3 minutes per day
Standard Deviation 11.6
|
5.2 minutes per day
Standard Deviation 16.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksThe activPAL accelerometer/inclinometer will measure minutes spent in sedentary activities (not including sleep). The average daily minutes of sedentary time will be the total minutes divided by the number of days the activPAL monitor was worn.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=31 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=31 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Objective Measures of Sedentary Activity
|
-10.1 minutes per day
Standard Deviation 66.5
|
-4.4 minutes per day
Standard Deviation 58.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksSelf-reported fatigue will be assessed using the PROMIS® Item Bank v1.0 - Fatigue - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse fatigue.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Fatigue
|
-0.31 points
Standard Deviation 4.20
|
-2.97 points
Standard Deviation 6.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksSelf-reported pain will be assessed using the PROMIS® Item Bank v1.0 - Pain Interference - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse pain.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Pain
|
0.41 points
Standard Deviation 6.63
|
-0.91 points
Standard Deviation 5.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksSelf-reported sleep disturbance will be assessed using the PROMIS® Item Bank v1.0 - Sleep Disturbance - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of greater sleep disturbance.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Sleep Disturbance
|
-0.78 points
Standard Deviation 4.71
|
-2.38 points
Standard Deviation 4.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksSelf-reported sleep impairment will be assessed using the PROMIS® Item Bank v1.0 - Sleep-Related Impairment - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater sleep impairment.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Sleep Impairment
|
0.22 points
Standard Deviation 3.89
|
-1.09 points
Standard Deviation 4.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksSelf-reported ability to participate in social roles and activities will be assessed using the PROMIS® Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater social participation.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Social Participation
|
-1.28 points
Standard Deviation 5.59
|
1.00 points
Standard Deviation 5.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksSelf-reported anxiety will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater anxiety.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Anxiety
|
-0.75 points
Standard Deviation 3.10
|
-0.47 points
Standard Deviation 3.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksSelf-reported depression will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Depression - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater depression.
Outcome measures
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 Participants
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 Participants
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
Change in Self-reported Depression
|
-1.94 points
Standard Deviation 4.83
|
0.19 points
Standard Deviation 2.97
|
Adverse Events
Experimental: Immediate Fitbit Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparator: Delayed Fitbit Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: Immediate Fitbit Intervention
n=32 participants at risk
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
Comparator: Delayed Fitbit Intervention
n=32 participants at risk
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
|
|---|---|---|
|
General disorders
Fall
|
0.00%
0/32 • 6 months
|
3.1%
1/32 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place